The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)

This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are: 1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with MSS, mCRC who have progressed on prior treatment before participating in the study. 2. Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.

NCT Number	NCT06699836
Lead Sponsor	CytoDyn, Inc. Collaborators: Syneos Health
Conditions	Metastatic Colorectal Cancer (mCRC)
Enrollment	66 participants
Start Date	2025-06-16
Primary Completion	2028-01 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-05-18